The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Dinamap Pro Series Monitor, Models 100, 200, 300, 400.
| Device ID | K992638 |
| 510k Number | K992638 |
| Device Name: | DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | Thomas English |
| Correspondent | Thomas English CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-06 |
| Decision Date | 2000-02-24 |
| Summary: | summary |